81_FR_87798 81 FR 87565 - Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability

81 FR 87565 - Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 233 (December 5, 2016)

Page Range87565-87566
FR Document2016-29117

The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``Health Document Submission Requirements for Tobacco Products.'' The guidance provides information to assist persons making health document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. We received several comments to the draft guidance, and those comments were considered as the guidance was finalized.

Federal Register, Volume 81 Issue 233 (Monday, December 5, 2016) 
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87565-87566]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29117]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0600]


Health Document Submission Requirements for Tobacco Products; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a revised guidance for industry entitled ``Health 
Document Submission Requirements for Tobacco Products.'' The guidance 
provides information to assist persons making health document 
submissions to FDA as required by the Family Smoking Prevention and 
Tobacco Control Act. We received several comments to the draft 
guidance, and those comments were considered as the guidance was 
finalized.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0600 for ``Health Document Submission Requirements for 
Tobacco Products.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be

[[Page 87566]]

made publicly available, submit your comments only as a written/paper 
submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Center for Tobacco Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send two self-addressed adhesive labels to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002, 1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a revised guidance for 
industry entitled ``Health Document Submission Requirements for Tobacco 
Products.''
    The revised guidance includes guidance for manufacturers or 
importers of newly deemed tobacco products that are subject to chapter 
IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 
U.S.C. 387). Cigarettes, cigarette tobacco, roll-your-own, and 
smokeless tobacco were immediately subject to chapter IX of the FD&C 
Act, including section 904(a)(4), which requires the submission of 
certain health documents. Section 901(b) of the FD&C Act grants FDA 
authority to deem all other tobacco products subject to chapter IX of 
the FD&C Act as well. Pursuant to that authority, FDA issued a final 
rule deeming all other products that meet the statutory definition of 
``tobacco product,'' set forth in section 201(rr) of the FD&C Act (21 
U.S.C. 321(rr)), except for accessories of those products, subject to 
the Chapter IX of the FD&C Act (81 FR 28973). FDA published the final 
rule on May 10, 2016 (81 FR 28973) and it became effective on August 8, 
2016. Therefore, manufacturers and importers of such tobacco products 
are now required to comply with chapter IX of the FD&C Act, including 
section 904(a)(4).

II. Significance of Guidance

    FDA is issuing this guidance consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on health document submission requirements. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance also refers to previously approved collections of 
information found in FDA statute. The guidance includes information and 
recommendations for how to provide health document submissions. The 
collections of information in section 904 (a)(4) of the FD&C Act have 
been approved under OMB control number 0910-0654.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: November 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29117 Filed 12-2-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 87565 drug labeling under the PLR (21 CFR product labeling. It does not establish DATES: Submit either electronic or 201.57(c)(13)) and provides guidance on any rights for any person and is not written comments on Agency guidances the inclusion of clinical binding on FDA or the public. You can at any time. recommendations based on clinical use an alternative approach if it satisfies ADDRESSES: You may submit comments pharmacology findings in other sections the requirement of the applicable as follows: of the labeling. The guidance is also statutes and regulations. intended to ensure consistency, as Electronic Submissions appropriate, in labeling of the III. The Paperwork Reduction Act of Submit electronic comments in the CLINICAL PHARMACOLOGY section 1995 following way: for all prescription drug products This guidance refers to previously • Federal eRulemaking Portal: http:// approved by FDA. approved collections of information that www.regulations.gov. Follow the This guidance provides a general are subject to review by the Office of instructions for submitting comments. framework and set of recommendations Management and Budget (OMB) under Comments submitted electronically, that should be adapted to specific drugs the Paperwork Reduction Act of 1995 including attachments, to http:// and their conditions of use. Not all of (44 U.S.C. 3501–3520). The collections www.regulations.gov will be posted to the information identified in this of information in 21 CFR 201.56 and the docket unchanged. Because your guidance for inclusion in the CLINICAL 201.57 have been approved under OMB comment will be made public, you are PHARMACOLOGY section of product control number 0910–0572; the solely responsible for ensuring that your labeling will be applicable for every collections of information related to comment does not include any drug. For the purposes of this notice, all pharmacogenomic data have been confidential information that you or a references to drugs include both human approved under OMB control number third party may not wish to be posted, drugs and biological products unless 0910–0557. such as medical information, your or otherwise specified. anyone else’s Social Security number, or The guidance outlines the use of IV. Electronic Access confidential business information, such subsections, headings, and subheadings Persons with access to the Internet as a manufacturing process. Please note to provide organization for the may obtain the document at either that if you include your name, contact CLINCAL PHARMACOLOGY section in http://www.fda.gov/Drugs/Guidance information, or other information that labeling. The guidance also emphasizes ComplianceRegulatoryInformation/ identifies you in the body of your the importance of providing variability Guidances/default.htm, http:// comments, that information will be measures related to pharmacokinetic www.fda.gov/BiologicsBloodVaccines/ posted on http://www.regulations.gov. measures and parameters, GuidanceComplianceRegulatory • If you want to submit a comment pharmacodynamic measures, and other Information/Guidances/default.htm, or with confidential information that you clinical pharmacology study results. https://www.regulations.gov. do not wish to be made available to the In addition to clarifications and edits public, submit the comment as a throughout the guidance on various Dated: November 29, 2016. written/paper submission and in the subsections of section 12, some notable Leslie Kux, manner detailed (see ‘‘Written/Paper changes from the revised draft guidance Associate Commissioner for Policy. Submissions’’ and ‘‘Instructions’’). include: [FR Doc. 2016–29125 Filed 12–2–16; 8:45 am] • Addressing whether applicants are BILLING CODE 4164–01–P Written/Paper Submissions expected to revise current approved Submit written/paper submissions as labeling if reserved sections 12.4 and follows: 12.5 have already been used for other DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for topics, and HUMAN SERVICES written/paper submissions): Division of • Providing revised recommendations Dockets Management (HFA–305), Food on the inclusion of pregnancy and Food and Drug Administration and Drug Administration, 5630 Fishers lactation information to be consistent Lane, Rm. 1061, Rockville, MD 20852. [Docket No. FDA–2009–D–0600] with recommendations in FDA’s • For written/paper comments ‘‘Pregnancy and Lactation Labeling Health Document Submission submitted to the Division of Dockets Rule’’ (https://www.federalregister.gov/ Requirements for Tobacco Products; Management, FDA will post your documents/2014/12/04/2014-28241/ Guidance for Industry; Availability comment, as well as any attachments, content-and-format-of-labeling-for- except for information submitted, human-prescription-drug-and- AGENCY: Food and Drug Administration, marked and identified, as confidential, biological-products-requirements-for) HHS. if submitted as detailed in (December 2014) and draft guidance for ACTION: Notice of availability. ‘‘Instructions.’’ industry entitled ‘‘Pregnancy, Lactation, Instructions: All submissions received and Reproductive Potential: Labeling for SUMMARY: The Food and Drug must include the Docket No. FDA– Human Prescription Drug and Biological Administration (FDA or we) is 2009–D–0600 for ‘‘Health Document Products—Content and Format’’ (http:// announcing the availability of a revised Submission Requirements for Tobacco www.fda.gov/downloads/drugs/ guidance for industry entitled ‘‘Health Products.’’ Received comments will be guidancecomplianceregulatory Document Submission Requirements for placed in the docket and, except for information/guidances/ucm425398.pdf) Tobacco Products.’’ The guidance those submitted as ‘‘Confidential provides information to assist persons sradovich on DSK3GMQ082PROD with NOTICES (December 2014). Submissions,’’ publicly viewable at This guidance is being issued making health document submissions to http://www.regulations.gov or at the consistent with FDA’s good guidance FDA as required by the Family Smoking Division of Dockets Management practices regulation (21 CFR 10.115). Prevention and Tobacco Control Act. between 9 a.m. and 4 p.m., Monday The guidance represents the current We received several comments to the through Friday. thinking of FDA on inclusion of clinical draft guidance, and those comments • Confidential Submissions—To pharmacology information in section 12 were considered as the guidance was submit a comment with confidential CLINICAL PHARMACOLOGY of finalized. information that you do not wish to be VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1

87566 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices made publicly available, submit your I. Background Dated: November 29, 2016. comments only as a written/paper FDA is announcing the availability of Leslie Kux, submission. You should submit two a revised guidance for industry entitled Associate Commissioner for Policy. copies total. One copy will include the ‘‘Health Document Submission [FR Doc. 2016–29117 Filed 12–2–16; 8:45 am] information you claim to be confidential Requirements for Tobacco Products.’’ BILLING CODE 4164–01–P with a heading or cover note that states The revised guidance includes ‘‘THIS DOCUMENT CONTAINS guidance for manufacturers or importers CONFIDENTIAL INFORMATION.’’ The of newly deemed tobacco products that DEPARTMENT OF HEALTH AND Agency will review this copy, including are subject to chapter IX of the Federal HUMAN SERVICES the claimed confidential information, in Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387). Cigarettes, Food and Drug Administration its consideration of comments. The second copy, which will have the cigarette tobacco, roll-your-own, and [Docket No. FDA–1999–D–1875] claimed confidential information smokeless tobacco were immediately redacted/blacked out, will be available subject to chapter IX of the FD&C Act, Compliance Policy Guide Sec. 615.115 for public viewing and posted on http:// including section 904(a)(4), which on Extralabel Use of Medicated Feeds www.regulations.gov. Submit both requires the submission of certain for Minor Species; Availability copies to the Division of Dockets health documents. Section 901(b) of the AGENCY: Food and Drug Administration, Management. If you do not wish your FD&C Act grants FDA authority to deem HHS. all other tobacco products subject to name and contact information to be ACTION: Notice of availability. chapter IX of the FD&C Act as well. made publicly available, you can Pursuant to that authority, FDA issued SUMMARY: The Food and Drug provide this information on the cover a final rule deeming all other products Administration (FDA or Agency) is sheet and not in the body of your that meet the statutory definition of comments and you must identify this announcing the availability of a revised ‘‘tobacco product,’’ set forth in section Compliance Policy Guide (CPG) 615.115 information as ‘‘confidential.’’ Any 201(rr) of the FD&C Act (21 U.S.C. entitled ‘‘Extralabel Use of Medicated information marked as ‘‘confidential’’ 321(rr)), except for accessories of those Feeds for Minor Species.’’ In advance of will not be disclosed except in products, subject to the Chapter IX of the January 1, 2017, date on which we accordance with 21 CFR 10.20 and other the FD&C Act (81 FR 28973). FDA anticipate that a number of drugs will applicable disclosure law. For more published the final rule on May 10, convert from over-the-counter (OTC) to information about FDA’s posting of 2016 (81 FR 28973) and it became veterinary feed directive (VFD) status, comments to public dockets, see 80 FR effective on August 8, 2016. Therefore, this revised CPG clarifies policy and 56469, September 18, 2015, or access manufacturers and importers of such regulatory action guidance to FDA staff the information at: http://www.fda.gov/ tobacco products are now required to on the Agency’s exercise of regulatory regulatoryinformation/dockets/ comply with chapter IX of the FD&C discretion with regard to the extralabel default.htm. Act, including section 904(a)(4). use of medicated feeds containing those Docket: For access to the docket to II. Significance of Guidance drugs in minor species. read background documents or the FDA is issuing this guidance DATES: The Agency is soliciting public electronic and written/paper comments consistent with FDA’s good guidance comment, but is implementing this CPG received, go to http:// practices regulation (21 CFR 10.115). immediately because the Agency has www.regulations.gov and insert the The guidance represents the current determined that prior public docket number, found in brackets in the thinking of FDA on health document participation is not feasible or heading of this document, into the submission requirements. It does not appropriate. You may submit either ‘‘Search’’ box and follow the prompts establish any rights for any person and electronic or written comments on and/or go to the Division of Dockets is not binding on FDA or the public. Agency guidances at any time. Management, 5630 Fishers Lane, Rm. You can use an alternative approach if ADDRESSES: You may submit comments 1061, Rockville, MD 20852. it satisfies the requirements of the as follows: Submit written requests for single applicable statutes and regulations. Electronic Submissions copies of the guidance to the Center for III. Paperwork Reduction Act of 1995 Submit electronic comments in the Tobacco Products, Food and Drug following way: Administration, 10903 New Hampshire This guidance also refers to previously approved collections of • Federal eRulemaking Portal: Ave., Document Control Center, Bldg. https://www.regulations.gov/. Follow information found in FDA statute. The 71, Rm. G335, Silver Spring, MD 20993– the instructions for submitting guidance includes information and 0002. Send two self-addressed adhesive comments. Comments submitted recommendations for how to provide labels to assist that office in processing electronically, including attachments, to health document submissions. The your requests. See the SUPPLEMENTARY collections of information in section 904 https://www.regulations.gov/ will be INFORMATION section for electronic posted to the docket unchanged. (a)(4) of the FD&C Act have been access to the guidance document. approved under OMB control number Because your comment will be made FOR FURTHER INFORMATION CONTACT: 0910–0654. public, you are solely responsible for Katherine Collins, Center for Tobacco ensuring that your comment does not IV. Electronic Access include any confidential information sradovich on DSK3GMQ082PROD with NOTICES Products, Food and Drug Administration, 10903 New Hampshire Persons with access to the Internet that you or a third party may not wish Ave., Document Control Center, Bldg. may obtain an electronic version of the to be posted, such as medical 71, Rm. G335, Silver Spring, MD 20993– guidance at either http:// information, your or anyone else’s www.regulations.gov or http:// Social Security number, or confidential 0002, 1–877–287–1373, email: AskCTP@ www.fda.gov/TobaccoProducts/ business information, such as a fda.hhs.gov. Labeling/RulesRegulationsGuidance/ manufacturing process. Please note that SUPPLEMENTARY INFORMATION: default.htm. if you include your name, contact VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1


Document Created: 2016-12-03 00:26:01
Document Modified: 2016-12-03 00:26:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactKatherine Collins, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993- 0002, 1-877-287-1373, email: [email protected]
FR Citation81 FR 87565 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR